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Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is comprised of the following devices:

• Penumbra Reperfusion Catheter
• Penumbra 3D Revascularization Device
• Penumbra Aspiration Pump
• Penumbra Aspiration Pump Canister
• Penumbra Aspiration Tubing
• Penumbra Separator

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an ID of 0.054 in. [1.37 mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

The Penumbra System (Reperfusion Catheter RED 43) is a medical device used for the revascularization of patients with acute ischemic stroke. The device's acceptance criteria and performance were evaluated through a series of design verification tests, as detailed in the FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the design verification. It only indicates that "the subject device met all established requirements."
The data provenance is from benchtop testing, which is a prospective method of evaluation performed in a controlled laboratory setting. There is no mention of country of origin for the data as it's not a clinical study.

3. Number of Experts and their Qualifications for Ground Truth:
This information is not provided in the document as the device's performance was evaluated through benchtop testing, not through expert-reviewed clinical data. Therefore, the concept of "experts establishing ground truth" in the context of clinical outcomes or imaging interpretations does not apply here.

4. Adjudication Method for the Test Set:
The concept of an adjudication method (like 2+1, 3+1) is typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Since the testing involved design verification and benchtop methods, such an adjudication method was not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers' improvement with AI assistance.

6. Standalone Performance:
The performance described is essentially standalone (algorithm only without human-in-the-loop performance), as it pertains to the physical and functional characteristics of the device itself as evaluated through bench testing. There is no "human-in-the-loop" component in the described verification tests.

7. Type of Ground Truth Used:
The ground truth used was based on ** predefined product specifications and established test methods** (e.g., ISO standards, internal design requirements) for each performance criterion. This is a form of technical and engineering ground truth rather than clinical, pathological, or outcomes data.

8. Sample Size for the Training Set:
A "training set" is typically associated with machine learning or AI models. Since this submission focuses on the physical device's performance through bench testing and explicitly states no animal or clinical studies were conducted, there is no mention or relevance of a training set in this context.

9. How the Ground Truth for the Training Set Was Established:
As there was no training set for an AI model, the concept of establishing ground truth for a training set is not applicable to this submission.

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Penumbra Aspiration Catheters and Separators: As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing: As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology. The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using an Aspiration Catheter with an I.D. of 0.054 in or larger. The Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy. The Penumbra Pump MAX is the aspiration source for the Penumbra Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions. The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

The provided document is a 510(k) premarket notification for the Penumbra Aspiration System. It details the device's indications for use, its classification, and a comparison to predicate and reference devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical (benchtop) and animal study data, largely leveraging existing data from previously cleared similar devices.

Crucially, this document does NOT contain information about specific "acceptance criteria" or "device performance" in terms of clinical outcomes, nor does it describe a study involving human subjects or experts for establishing ground truth for AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified sub-points (table of acceptance criteria/performance, sample size, experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details) because this information is not present in the provided text.

The document discusses:

• Leveraged Non-Clinical Data (Section 1.10): This section lists benchtop tests (Friction, Visual & Dimensional, Pouch Seal Strength, Flow Rate, Tensile, Elongation, Bond Strength, Hub Air Aspiration, Torsion, Burst, Simulated Use, Particulate, Flexibility, Packaging, Corrosion). It states that "all established requirements and acceptance criteria were met," but it does not specify what those acceptance criteria were in measurable terms (e.g., "flow rate X L/min," "tensile strength Y N"). It also does not define "device performance" in the way requested (e.g., diagnostic accuracy, sensitivity, specificity).
• Leveraged Animal Studies (Section 1.11): This section summarizes findings from design validation in GLP animal testing, noting "No vessel injury," "No abnormal gross or histology findings," and "no significant vascular response." This is performance data in an animal model, but not clinical performance in humans, nor does it relate to acceptance criteria for an AI/algorithm-driven device.

In summary, the provided text describes the regulatory clearance process for a medical device (an aspiration system) based on substantial equivalence to existing devices, supported by benchtop testing and animal studies. It does not contain the kind of information typically found in a study proving an AI/algorithm-driven device meets specific clinical acceptance criteria, which would involve human data, expert review, and metrics like accuracy, sensitivity, or specificity.

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Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Penumbra Aspiration Tubing: As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in [1.37mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.

The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the KIT configuration, as that's where new testing was performed:

1. Table of Acceptance Criteria and Reported Device Performance (KIT Configuration)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the "Design Verification testing" for the KIT configuration. It only mentions "units used in this Design Verification testing" for Visual Inspection, and implicitly for Simulated Use, Catheter Coating, and Gross Leak tests as they all report 100% Pass.

• Sample Size: Not explicitly stated as a number, but all tested units passed.
• Data Provenance: The tests are described as "additional testing performed for the KIT configuration packaging," suggesting these are prospective, benchtop tests conducted by Penumbra, Inc. The country of origin for the data generation would logically be the USA, given the company's location.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts or clinicians being used to establish a ground truth for these non-clinical tests. The tests are focused on physical and mechanical properties and simulated use in anatomical models.

4. Adjudication Method for the Test Set

Not applicable, as these are non-clinical, objective tests and not based on expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document describes a medical device (Penumbra System and Penumbra Pump MAX) for treating acute ischemic stroke, not an AI-based diagnostic or treatment guidance system that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:
* Defined specifications and performance expectations: For Visual Inspection, Catheter Coating, and Gross Leak, the "ground truth" is adherence to predefined quality and integrity standards.
* Simulated physiological conditions and objective performance: For Simulated Use, the "ground truth" is the effective removal of clots and prevention of catheter collapse in an anatomical model that mimics neurovasculature.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for test sets, where applicable)

• Biocompatibility Testing:

  • In Vitro Cytotoxicity: Not specified in terms of sample size for the test itself, but implies multiple samples for extract testing.
  • Sensitization: "Test Group" - size not specified.
  • Acute Intracutaneous Reactivity: "mean test article and mean control score" - implies multiple samples, size not specified.
  • Acute Systemic Toxicity: "3 or more test animals" (for weight loss criteria), "2 or more test animals" (for morality/behavior) - implies at least 3 animals for each extract/test (likely mice or rats, as common for this test).
  • Rabbit Pyrogen Study: "No single animal" suggests multiple rabbits, specific number not stated.
  • Hemocompatibility In Vitro Hemolysis: Sample extracts, size not specified.
  • Complement Activation: "test samples" compared to "predicate (Exposure Control & Ref Material) control" and "positive control" at "all three exposure times." Specific number of samples not stated.
  • Dog Thrombogenicity: "2 out of 2 test site and 2 out of 2 control sites" - suggests at least two test animals (dogs) for the in-vivo evaluation.
  • Data Provenance: Retrospective, conducted by the manufacturer, or by external labs following GLP. Country of origin not specified, but following EN ISO 10993 guidelines.

• Bench-top Testing:

  • Sample sizes are not explicitly stated for all individual tests, but most indicate "100% Pass," which suggests the testing was performed on a sample of devices and all met the criteria. For particulate testing, the maximum number suggests a specific measurement from a sample.
  • Data Provenance: Retrospective, conducted by the manufacturer.

• Animal Study:

  • Sample Size: A "swine model" was used. The number of individual animals (swine) is not explicitly stated, but the conclusions "No vessel injury was noted on the final angiograms following the vessel response procedure," "No abnormal gross or histology findings were noted in test vessel segments," and "The use of the Penumbra System ACE devices resulted in no significant vascular response in these experimental conditions," suggest sufficient animal subjects were used to support the claim.
  • Data Provenance: Prospective, animal study (GLP Animal Testing).

3. Number of Experts Used and Qualifications (for ground truth establishment)

• Biocompatibility Testing: Experts in toxicology, microbiology, and animal studies would have been involved in the design and interpretation of these studies. Their specific number and qualifications are not detailed in this summary.
• Bench-top Testing: Engineers and material scientists within the manufacturer's R&D and Quality departments would have developed the specifications and assessed the results.
• Animal Study: Veterinarians, interventionalists (to perform the procedures), pathologists (for gross and histology findings), and researchers expert in animal models for vascular devices.
• Note: This document does not pertain to AI/ML or image data, so the concept of experts establishing ground truth for a test set (e.g., radiologist for image interpretation) as typically understood in AI studies is not directly applicable here. The "ground truth" here is physical/biological measurements and observations.

4. Adjudication Method (for the test set)

• Not applicable in the context of this device's non-clinical testing. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation where there is subjective assessment by multiple human readers (e.g., radiologists) that needs to be reconciled to establish a ground truth. The tests described are objective physical, chemical, or biological measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This document describes the pre-market non-clinical testing of a physical medical device (catheter), not an AI/ML algorithm for diagnostic imaging or similar applications where human reader performance is augmented.

6. Standalone (Algorithm Only) Performance Study

• No, this is not an AI/ML device. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

• Biocompatibility Testing: The ground truth is objective biological and chemical reactions/measurements (e.g., cell lysis grade, inflammation scores, weight changes, temperature changes, hemolytic index, C3a/SC5b-9 concentrations, histopathology for thrombogenicity).
• Bench-top Testing: The ground truth is objective physical and mechanical measurements against technical specifications (e.g., dimensions, force measurements, flow rates, visual integrity, particulate counts).
• Animal Study: The ground truth is direct in-vivo observation and pathological assessment (e.g., angiographic evidence of injury, gross pathology findings, histological examination of vessel segments).

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices involves engineering design, material selection, and iterative prototyping based on established engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the AI/ML sense for this device. The development process relies on engineering specifications, material science data, and established test methods, rather than a labeled dataset for algorithm training.

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The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

The Penumbra System MAX components are additional components of the currently available Penumbra System. The Penumbra System MAX components provide a larger lumen to assist in the efficient removal of thrombus from the brain. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The Penumbra System® MAX components are additional components of the currently available Penumbra System. The summary of non-clinical data details the testing that substantiates the safe and effective performance of the Neuron MAX System and its substantial equivalence to predicate devices. This includes Biocompatibility testing, Design Verification (Bench-Top Testing), and an Animal study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria for each test were "Pass," meaning the device met the established requirements for each attribute.

2. Sample Size Used for the Test Set and the Data Provenance

• Bench-top Testing: Sample sizes for individual tests ranged from 3 to 30 units (e.g., N=30 for Pouch Seal Strength, N=10 for Particulate Testing, N=3 for Flow Rate). The data provenance is internal laboratory testing ("All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements."). This is considered retrospective data from a manufacturing/design verification process.
• Biocompatibility Testing: The document does not specify exact sample sizes for each biocompatibility test but states that "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," which implies standard laboratory animal testing where applicable (e.g., Rabbit Pyrogen Study, Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Sensitization). This data is from controlled laboratory experiments.
• Animal Study: The document mentions "An animal study was conducted to evaluate the safe use of the Penumbra System MAX in a swine model." The exact sample size for the animal study is not explicitly provided in the summary, but it refers to "experimental conditions" and "test vessel segments," suggesting a controlled study within a lab setting. This is prospective animal data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

Not applicable. The studies described are non-clinical (bench-top, biocompatibility, animal studies) and do not involve human diagnostic or treatment decision-making where expert consensus would establish ground truth for a test set. The "ground truth" here is determined by objective physical, mechanical, biological, or physiological measurements against predefined engineering and biological safety standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical studies. The results are objective measurements/observations (e.g., "Pass," "No evidence of toxicity," "No vessel injury") rather than interpretations requiring adjudication among human experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes the safety and effectiveness testing of a physical medical device (catheter system) for mechanical thrombus removal, not an AI or imaging-based diagnostic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for these non-clinical studies was established by:

• Predefined engineering specifications and performance parameters for mechanical and physical properties.
• Established international and national standards for biocompatibility (e.g., ISO 10993, USP, ASTM, 21 CFR Part 58).
• Physiological observations, angiographic evaluations, gross pathology, and histology in the animal model.

8. The Sample Size for the Training Set

Not applicable. This document refers to the testing of a physical medical device. There is no "training set" in the context of machine learning or AI. The design verification and biocompatibility testing involved various "test units" or "samples" for specific tests, as detailed in the table, to ensure the device met its design specifications.

9. How the Ground Truth for the Training Set was Established

Not applicable, for the same reason as #8. Ground truth in this context refers to the defined specifications and standards the device was designed to meet and was tested against.

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The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

The Penumbra System Separator Flex (026, 032, 041, and 054) is an alternative to the current Penumbra System Separators. The Separator Flex utilizes a Nitinol core wire in place of the current stainless steel corewire. The Flex utilizes a Nitinol core wire in all four current sizes (026, 032, 041, and 054). Both the existing Separators and the subject Separator Flex models will be available to address Physician preference of stainless steel and nitinol. The device is provided sterile, nonpyrogenic, and intended for single use only.

The Penumbra System® Separator™ Flex (K100769) is a medical device intended for the revascularization of patients with acute ischemic stroke. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided document does not specify the exact sample sizes for each non-clinical test (biocompatibility and bench-top testing). However, it states that "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices" for biocompatibility, and for design verification, "All testing was performed using units which met applicable Design Control processed goods release requirements." This indicates that standard laboratory testing practices were followed to ensure sufficient sample sizes for statistically valid results, even if the explicit numbers are not given.

The data provenance is from non-clinical studies conducted by Penumbra, Inc. in the USA (Alameda, CA), as indicated by the sponsor's address and the regulatory context of a 510(k) submission to the FDA. The testing can be considered prospective in the sense that it was specifically designed and executed to support the regulatory submission for this new device.

3. Number of Experts and Qualifications for Ground Truth

This submission pertains to a medical device (catheter/separator) and relies on non-clinical data (biocompatibility and bench-top testing) rather than clinical data requiring expert review of medical images or patient outcomes. Therefore, the concept of "ground truth" derived from experts, as typically understood in studies involving diagnostic devices or AI algorithms, does not apply in this context. The "ground truth" for these tests is based on established scientific methods and pass/fail criteria.

4. Adjudication Method for the Test Set

As the studies are non-clinical (biocompatibility and bench-top testing), an adjudication method in the context of expert review (e.g., 2+1, 3+1) is not applicable. The results are determined by objective measurements and analyses performed according to established scientific protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a medical device (catheter) and not a diagnostic imaging AI algorithm, so such a study design is generally not relevant. The effectiveness is demonstrated through pre-clinical performance testing.

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of the "Design Verification (Bench-Top Testing)". This section evaluates the physical, mechanical, and performance characteristics of the Penumbra System Separator Flex on its own, without human intervention during the actual tests (after the device is assembled and prepared for testing). The tests included:

• Dimensional / Visual Inspection
• Simulated Use (Reperfusion Catheter / Separator Flex / Aspiration Tubing Assembly Performance)
• Separator Flexibility Test
• Separator Flex Bond Joint Test

These tests demonstrate the intrinsic performance of the device against predefined specifications.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical studies is based on established scientific and engineering standards and methods.

• For biocompatibility, the ground truth is defined by the accepted criteria outlined in ISO-10993 - I (Biological Evaluation of Medical Devices) for various biological responses (cytotoxicity, irritation, systemic toxicity, pyrogenicity, sensitization, hemolysis, coagulation, complement activation).
• For design verification (bench-top testing), the ground truth is based on engineering specifications, physical measurements, and functional performance criteria defined by the manufacturer to ensure the device operates as intended and meets safety and performance requirements.

8. Sample Size for the Training Set

Not applicable. This submission describes a physical medical device (catheter/separator), not an AI algorithm that requires a training set. The performance is assessed through bench-top testing and biocompatibility studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The ground truth for its performance is established through adherence to engineering design specifications, international standards (like ISO-10993), and good laboratory practices.

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